Perforator Handpiece 1700761-001

GUDID 17630055506518

Bien-Air Surgery SA

Manual cranial rotary handpiece, reusable

• Primary Device ID: 17630055506518
• NIH Device Record Key: abb0a426-737d-4f49-8d42-118cb08dd594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perforator Handpiece
• Version Model Number: 362640
• Catalog Number: 1700761-001
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17630055506518 [Primary]

FDA Product Code

• HBC: Motor, Drill, Electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-27
• Device Publish Date: 2023-03-17

Devices Manufactured by Bien-Air Surgery SA

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• 27630055514732 - Bur PM2-70 80K diam C Ø3.1 St: 2024-04-09
• 17630055515756 - Bur PM2-70 80K diam Ø0.6 St: 2024-04-09
• 17630055515763 - Bur PM2-70 80K diam Ø0.8 St: 2024-04-09
• 27630055515777 - Bur PM2-70 80K diam Ø1.0 St: 2024-04-09
• 27630055515784 - Bur PM2-70 80K diam Ø1.4 St: 2024-04-09
• 27630055515791 - Bur PM2-70 80K diam Ø1.8 St: 2024-04-09
• 27630055515807 - Bur PM2-70 80K diam Ø2.3 St: 2024-04-09